BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK 20

    MDR report key: 1840178 · Received September 14, 2010

    Report

    Report Number
    MW5017453
    Event Type
    Malfunction
    Date Received
    September 14, 2010
    Date of Event
    June 29, 2010
    Report Date
    September 14, 2010
    Manufacturer
    PHYSIO-CONTROL
    Product Code
    MKJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT CALLED RN INTO ROOM BECAUSE LIFEPAK WAS BEEPING AT APPROX 1600. MACHINE SIGNALING THE NEED TO BE PLUGGED IN. MACHINE PLUGGED BACK IN. CORD TO PATCHES WERE TANGLED AND THESE WERE DISENGAGED AND UNTIED THEN REATTACHED TO LIFEPAK. PT WAS THE HELPED TO MOVE IN BED. PT GASPED AND STATED THAT HE FELT A "SHOCK." NO CHANGES WERE SEEN ON MONITOR, NO NOISE FROM LIFEPAK WAS HEARD. RN WAS TOUCHING BED AND FELT NOTHING. PT HAS HAD SHARP PAIN WHEN MOVING IN PAST. MONITOR WAS CHECKED FOR EVENTS, NONE WERE FOUND. REPORTS WERE GENERATED FROM 1400-1730, NO CHANGES, SHOCKS, OR ECTOPY WERE SEEN. LIFEPAK IN ROOM WAS REPLACED. ON FURTHER INVESTIGATION WITH BIOMED THE NEXT DAY, IT WAS FOUND THAT THE LIFEPAK DID ACTUALLY DELIVER A SHOCK OF 200J AT 1711 ON THE 29TH OF JUNE. THERE WAS NO HARM TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEPAK 20 LIFEPAK 20 MKJ PHYSIO-CONTROL LIFEPAK 20 NONE

    Patients

    Seq Age Sex Outcome Treatment
    1